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CHI, BCG Issue Report on FDA's Drug Review Performance

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Even as FDA has made strides over the past two years to shorten drug approval timelines, the agency takes longer to approve drugs for diseases like cardiovascular disease, obesity, and diabetes than for several forms of cancer, hepatitis C, lupus, pneumonia, and orphan diseases, a report issued this morning concluded.

The California Healthcare Institute (CHI) and The Boston Consulting Group (BCG) found that oncology and anti-infective drugs experienced the fastest review timeframes at 10 to 15 months, compared with 20 to 30 months for other categories such as cardiovascular, central nervous system, gastrointestinal, and respiratory drugs.

“Regulatory pathways in these areas, however, are fraught with uncertainty. And the result is that fewer large pharmaceutical manufacturers are developing products for these indications, while venture funding for startups has all but disappeared,” the 12-page report concluded.

The report buttressed that point with a quote from Sanofi CEO Christopher Viehbacher: “You’re starting to see primary care diseases becoming somewhat neglected. To make sure we’re not ignoring unmet needs in primary care, we need a lot more clarity around the risk-benefit so there’s predictability when we invest in these products.”

The report also tied length of approvals to submission behavior by biopharma companies by noting significant jumps in the percentage of drugs in faster-review categories submitted to FDA for review between 2000–02 and 2009–11. During those period, oncology and immunomodulatory drugs zoomed from almost 20% to about 40%, while gastrointestinal and carviovascular drug submissions fell from about 7% to under 2%.

All but one of the drugs receiving faster approvals won them on or before target dates set in the Prescription Drug User Fee Act (PDUFA). Most of the drugs won approval during their first review cycle. Faster approvals were made possible, the report noted, through FDA’s use of expedited approval pathways that often streamlined clinical trials, allowing for smaller, shorter, or fewer studies. Since FDA began the accelerated approval process introduced in the first PDUFA, 81 products were approved through the faster reviews, of which 32 targeted AIDS and 29 cancer.

Another key factor: “For cancer drugs, FDA has been more willing to accept serious side effects and comparatively low response rates partly because there are no good alternative treatments and because patients’ lives hang in the balance.”

The CHI-BCG report noted the power of cancer and AIDS advocates to press for accelerated approvals by challenging FDA’s scientific and technical expertise, influencing the agency’s relationship with medical professionals and making appeals directly to Congress.

“Ultimately, in different ways, cancer and AIDS demonstrated the power of patient politics, especially in pressuring the FDA to adopt flexibility in its standards for safety and efficacy by taking into account the viewpoint of patients and the characteristics of their diseases,” the report stated. “In equal measure, this shaped the agency’s attitude toward benefits versus risk from one therapeutic area to another.”

For obesity drugs, on the other hand, FDA in 2007 issued draft guidance insisting on one-year trials with a minimum 4,500 patients: 3,000 randomized to the treatment under study and 1,500 to placebo. But the dropout rate for obesity trials ranges from 30% to 50%, resulting in longer times and steeper costs for such studies.

The report made no recommendations either for shortening requirements for obesity trials or for extending accelerated approvals to CV and obesity drugs. “That is a discussion that the agency and industry need to have,” CHI President and CEO David L. Gollaher, Ph.D., told GEN. “We wanted to step back and raise the question and then develop some data to answer the question: Is how the FDA prioritizes drug reviews and when it chooses to use the tools at its disposal for accelerated approvals align well or perfectly or not so well with public health needs?”

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